Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement

Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation, Persistent
• Intervention / Treatment: Procedure: Catheter ablation

Detailed Description

Long-term persistent atrial fibrillation (PerAF) may induce right atrial (RA) enlargement and subsequently atrial functional tricuspid regurgitation (AF-TR) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. Enlarged RA and significant AF-TR may aggravate atrial remodeling and contribute to AF sustaining. Previous studies showed that RA enlargement was closely related to the recurrence of AF after catheter ablation. However, unlike the left atrium, the RA mechanism has been poorly studied and generally excluded from the therapeutic target. In an animal model of right heart disease, the RA enlargement associated with re-entrant activity serves as the prominent mechanism of AF genesis. Using sophisticated mapping techniques, recent study has confirmed that up to one-third of AF drivers are located in the right atrium. Furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven AF have concomitant RA enlargement. Therefore, it is plausible to hypothesize that the presence of RA enlargement represents the necessity of adjunctive RA ablation. Currently, the value and timing of RA intervention are still under debate. Therefore, the purpose of the present study was to testify whether patients with PerAF and RA enlargement may benefit from adjunctive RA ablation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines;
• Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.

Exclusion Criteria:

• Uncontrolled congestive heart failure;
• History of severe valve disease and/or prosthetic valve replacement;
• Myocardial infarction or stroke within 6 months;
• Severe congenital heart disease;
• EF <40%;
• Contrast agent allergy;
• The use of anticoagulant drugs is contraindicated;
• Severe lung disease;
• Left atrial thrombus confirmed by preoperative esophageal ultrasound;
• Contraindications for cardiac catheterization;
• Atrial fibrillation ablation;
• Have performed any cardiac surgery within 2 months;
• Poor general health;
• Life expectancy < 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RA group; The RA group received adjunctive right atrial ablation in addition to left side ablation.	Procedure: Catheter ablation; The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation
Active Comparator: Control group; The control group received left side ablation only.	Procedure: Catheter ablation; The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation recurrence	any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation/atrial tachycardia recurrence	any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs treatment at 12 months after a single procedure or freedom from any AF episodes lasting more than 30 seconds occurring after the blanking period without the use of anti-arrhythmic drugs at the end of study follow-up after a single procedure.	12 months

Collaborators and Investigators

• Sponsor: Xu Liu
• Collaborators: The Third Xiangya Hospital of Central South University; Yangpu District Central Hospital Affiliated to Tongji University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; catheter ablation; Driver ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: KS(Y)23218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes